Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Const... | Completed
Efficacy and Safety of Naldemedine ... | Completed
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

Trial Source

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Medical Conditions
  • Opioid-induced Constipation
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01965158
Primary Trial ID Number

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Summary
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain who are not using laxatives
Research Details
  • This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of naldemedine 0.2 mg once daily versus placebo for the treatment of subjects with non-malignant chronic pain and OIC
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Naldemedine, Drug : Placebo

Study Arm Groups : Subjects on naldemedine, Subjects on placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Proportion of responders; 12 week treatment period
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - 80 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    1. Subjects aged 18 to 80 years inclusive at the time of informed consent

    2. Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC)

    3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate

    4. Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration

    5. Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary

    Exclusion Criteria:

    1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract

    2. Evidence of active medical diseases affecting bowel transit

    3. History or presence of pelvic disorders that may be a cause of constipation

    4. Surgery (except for minor procedures) within 60 days of Screening

    5. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical GI obstruction)

    6. Subjects who have never taken laxatives for the treatment of OIC

    7. History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of breast cancer

    8. Current use of any prohibited medication including opioid antagonists, partial agonists or mixed agonists/antagonists
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
London
Greater London
Belfast
Shionogi Research Site
Bexhill
Shionogi Research Site
Plymouth
Shionogi Research Site
Fowey
Shionogi Research Site
Liskeard
Shionogi Research Site
Penzance
Shionogi Research Site
Soham
Shionogi Research Site
Saint Austell
Shionogi Research Site
Balallan
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Czech Republic, Germany, Poland, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
1314V9231
Sponsor(s)
Shionogi
Key Dates

Recruitment Start Date

Aug 2013

Recruitment End Date

Jan 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

30 Sep 2013

Last Updated

13 Nov 2015